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Business decision.
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Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QuantiFERON CMV Assay | Device | Assay to measure cell-mediated immune function using QuantiFERON CMV assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in time to CMV Infection between sub-groups of QF-CMV assay classifications. | Measurement of QF-CMV result | At time of prophylaxis termination, +1 month from termination, +2 months from termination |
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Inclusion Criteria:
Exclusion Criteria:
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CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3. | ||
| 11229841 | Background | Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20. |
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Residual Plasma